Product Manual

Page 12
5. Warnings and Precautions
This test system is not recommended for patients
who have recently taken or are currently taking
any type of Heparin anticoagulants. The system
should also not be used to monitor patients on
direct oral anticoagulants (DOACs) including
Factor Xa and Direct Thrombin inhibitors.
Test Site and Blood Sample
• The Coag-Sense PT/INR system is for in vitro diagnostic use only.
• The Coag-Sense meter will not produce a result if the test strip is
past its expiration date.
• The quality of the blood sample can affect PT test results. A blood
sample of poor quality can produce unreliable results. Read the
section on “Collecting a Fingerstick Sample” for more information.
• Blood samples must be applied to the test strip immediately after
collection or the blood begins to clot, causing unreliable results.
• The blood sample transferred to the test strip must be a minimum
of 10 µL in volume. Low sample volume may cause an error
message.
• Use only fresh fingerstick capillary blood for testing. The blood
should only come in contact with the products provided with the
Coag-Sense PT/INR system. Other products may have anti-
coagulant agents on their surfaces and result in unreliable test
results.
• Squeezing the fingerstick site excessively (milking) releases
interstitial “tissue layer” fluid that can cause unreliable results.
• The fingerstick site can be washed with warm water and soap, and
then completely dried. The site must be clean of all hand oils/lotions
and foreign matter, which may cause unreliable results.
• If Isopropyl Alcohol (IPA) wipes are used, wipe the fingerstick
site with a gauze pad and make sure the site is completely dry.